Efficacy and Safety of Transcranial dIrect Current stiMulation in Multiple System Atrophy-Cerebellar Variant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorUniversity of Salerno
About this trial
This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) cerebellar symptoms in Multiple System Atrophy type C (MSA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Multiple system atrophy cerebellar variant according with the Movemente Disorder Society criteria (Wenning et al 2022)
Ability to walk either indipendently or with a minimum support
Disqualifiers
Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation, DBS)
Difficult in understanding Italian language
Presence of severe sensory deficits (for example, visual or hearing impairments)
History of drug abuse
Trial design
Design model
Crossover
Treatments tested in this trial
Anodal transcranial direct current stimulation (a-tDCS)
DevicetDCS is delivered by a battery-driven constant current stimulator throught a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the over the cerebellum area (2 cm under the inion, using a 7 × 5 cm sponge electrode), with the cathode being applied either to the right deltoid muscle (arm 1: cerebellar stimulation) or over the spinal lumbar enlargement (2 cm under T11; arm 2: cerebellar-spinal stimulation) using a sponge electrode of the same size as the anode. Durng real stilumation a costant current of 2mA is applied for 20 minutes.
Sham stimulation
DeviceFor the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Real tDCS groupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to 1 week and two weeks follow in motor symptoms as assessed with sensor recordings (OPAL system)
Change from baseline to 1 week and two weeks follow in motor symptoms as assessed with sensor recordings (OPAL system), movements will be recorded with digital sensors (gait and other tasks)
Time frame
Baseline (t0), at 1 week (t1), at 2 weeks (t2)Secondary outcomes
1
Changing from baseline of measures from clinical scale (SARA)
Changing from baseline of measures from clinical scale: SARA: Scale for the assessment and rating of ataxia
Time frame
Baseline (t0), at 1 week (t1), at 2 weeks (t2)2
Changing from baseline of measures from clinical scale (ICARS)
Changing from baseline of measures from clinical scale: ICARS: International cooperative ataxia rating scale
Time frame
Baseline (t0), at 1 week (t1), at 2 weeks (t2)3
Changing from baseline of measures from clinical scale (UMSARS)
Changing from baseline of measures from clinical scale: UMSARS: Unified multiple system atrophy rating scale
Time frame
Baseline (t0), at 1 week (t1), at 2 weeks (t2)4
Changing from baseline of measures from patient related outcome
Changing from baseline of measures from patient related outcome Euro 5 dimension quality of life (EQ5D)
Time frame
Baseline (t0), at 1 week (t1), at 2 weeks (t2)Sponsors and contacts
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Source ClinicalTrials.gov